U.S. is already way behind in terms of the number of biosimilar approvals. Over 45 biosimilars have been approved till date in Europe post the first approval in 2006. The U.S. FDA has approved only 16 biosimilars till December 2018. Although the biosimilar pipeline is growing significantly, patent extension strategies are hindering competitors from entering the market as soon as the main patent expires.
One perfect example to this is biosimilars of Humira. There is a strong pipeline of Humira biosimilar. Three biosimilars of Adalimumab have been approved by the U.S. FDA as of December 2018. However, none of these can be marketed until 2023, as Humira is protected by around 100 patents. Moreover, most of these patents has been granted recently, when Humira’s main drug patent was about to expire. Furthermore, below are the licensure deals done by Abbvie with biosimilar filers to protect its market share:
- Amgen: January 31, 2023
- Samsung Bioepis: June 30, 2023
- Mylan: July 31, 2023
- Fresenius Kabi: September 30, 2023
- Sandoz: September 30, 2023
- Momenta: November 20, 2023
- Pfizer: November 20, 2023
Moreover, Abbvie (now Abbott) is conducting phase 3 trial in pediatric patients for moderate to severe Ulcerative Colitis (study expected to be completed by September 2020). Approval for this additional indication will provide a boost to Humira’s revenue in 2021 and 2022. As per our estimates, the revenue of Humira is expected to surpass US$ 20 billion by 2022.
However, not all adalimumab biosimilar have been delayed for market entry. Boehringer Ingelheim (BI) received approval for Cyltezo in August 2017. However, unlike other companies, BI is challenging Abbvie in the court and determined to launch its biosimilar before 2023. Cyltezo, if launched, could have a significant impact on Humira and may also push other approved biosimilars to enter the market before 2023.
To analyze the pipeline of biologics and biosimilar, Coherent Market Insights have launched PHASE-XS, a comprehensive analytical database for biologics and biosimilar pipeline molecules. PHASE-XS, a market solution for biologics, includes clinical information along with analysis of phase 3 and phase 4 trials of biologics and biosimilars.
Benefits of PHASE-XS:
- Identify the potential competitors
- Identify target products for biosimilars through patent expiry of biologics
- Identify if there are any studies for the extension of indications of already approved products
- Identify the white spaces
- Identify the products with significant revenue opportunity
- Identify an ideal trail design with a competitive edge
- Actionable market forecast
- Identify the addressable patient pool
To know more about Phase-XS, please click the link below,